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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048478
Receipt No. R000055222
Scientific Title A single-arm exploratory study for the efficacy and safety of acupuncture in patients with taxane-induced peripheral neurotoxicity
Date of disclosure of the study information 2022/08/01
Last modified on 2022/07/27

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Basic information
Public title A single-arm exploratory study for the efficacy and safety of acupuncture in patients with taxane-induced peripheral neurotoxicity
Acronym ACT-1 study
Scientific Title A single-arm exploratory study for the efficacy and safety of acupuncture in patients with taxane-induced peripheral neurotoxicity
Scientific Title:Acronym ACT-1 study
Region
Japan

Condition
Condition taxane-induced peripheral neurotoxicity
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of acupuncture in patients with taxane-induced peripheral neurotoxicity.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in average pain intensity between baseline and week 16.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Acupuncture
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patient with breast cancer who had received curative treatment more than 3 months ago
2) Received taxane.
3) Have "mild" or severer symptom in PRO-CTCAE item 39b
4) 18 years or older
5) ECOG PS 0 or 1
Key exclusion criteria 1)Patient with peripheral neuropathy by other than taxane
2)have distant metastases or local recurrence
3)have fibromyalgia, inflammatory joint disease, or phantom limb pain
4)undergoing chemotherapy
5)have mental illness
6)have severe comorbidities
7)being pregnant or breastfeeding
8)history of acupuncture for CIPN
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Eriko
Middle name
Last name Satomi
Organization National Cancer Center Hospital
Division name Department of Palliative Medicine
Zip code 1040045
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL 0335422511
Email esatomi@ncc.go.jp

Public contact
Name of contact person
1st name Hiroto
Middle name
Last name Ishiki
Organization National Cancer Center Hospital
Division name Department of Palliative Medicine
Zip code 1040045
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL 0335422511
Homepage URL
Email hishiki@ncc.go.jp

Sponsor
Institute National Cancer Center Hospiatl
Department of Palliative Medicine
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Cancer Center Institutional Review Board
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo
Tel 0335422511
Email irst@ml.res.ncc.go.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2022 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2022 Year 06 Month 28 Day
Date of IRB
Anticipated trial start date
2022 Year 09 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 07 Month 27 Day
Last modified on
2022 Year 07 Month 27 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055222

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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